Remote Monitoring Use In Cases Of Suspected COVID-19 (Coronavirus)

Coronavirus Clinical Trial

— REMOTE-COVID  

Official title:

REmote MOniToring usE in Suspected Cases of COVID-19 (Coronavirus): REMOTE-COVID Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04337489
• Other study ID #: REMOTE-COVID
• Status: Completed
• Start date: July 28, 2020
• Est. completion date: March 26, 2021

Study information

• Verified date: February 2022
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims to see if participant deterioration due to suspected coronavirus in a designated location (e.g. hotel) can be identified sooner by wearing the sensor. If sick patients can be identified early, participants are more likely to have better outcomes; the study believes that the sensor can help us do this. The sensor measures heart rate, respiratory rate and temperature every 2 minutes and this can be reviewed by the clinical team looking after the participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 26, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Aged 18 years or over.

• Able to provide written consent.

Exclusion Criteria:

• Any participants that withdraw their consent.

• A skin condition/reaction preventing wearing the wearable sensor.

• The presence of a permanent pacemaker or cardiac defibrillator.

• Any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the research team.

• Inability to cooperate or communicate with the research team.

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections

Intervention

Device:
• SensiumVitals wearable sensor
A waterproof, light, wearable sensor measuring vital signs (heart rate, respiratory rate, temperature) continuously.

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	CW+ Charity

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deterioration resulting in healthcare review	Detection of clinical deterioration using wearable sensors resulting in healthcare review (e.g. GP telephone consultation)	1 year
Secondary	Hospitalisation	Deterioration resulting in hospitalisation	1 year
Secondary	Participant anxiety	General Anxiety Disorder (GAD-7) questionnaire (responses noted on Likert scales); min score 0 and max score 21. Higher score associated with greater anxiety	1 year
Secondary	Participant depression	Patient Health Questionnaire (PHQ-9) questionnaire (responses noted on Likert scales); min score 0 and max score 27. Higher score associated with greater depression.	1 year

External Links

•   Published article
•   Trial Protocol